Regulatory Project Manager/Lead

Onsite in Munich

This position covers the project management of regulatory activities from early development, i.e. pre-clinical scientific advice to Project Management of dossier preparation for MAA or BLA/NDA filing. Therefore extensive experience of regulatory drug development activities is a requirement. 

Tasks & Responsibilities:
Manage EU and FDA drug development and Marketing Authorisation Application procedures including:

• 1. preparation of Module 1 documents
  2. assignment and management of team resources
  3. co-ordination of Mod 2 & 3
  4. tracking Modules 4 & 5
  5. preparation and track project plans
  6. interaction with Regulatory Agencies on behalf of clients before, during and after approval
  7. management the MAA procedure on behalf of clients
• Provide regulatory advice to clients
• Prepare and manage project plans
• Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation

 Requirements:

• Masters or PhD. in life sciences, medicine or veterinary medicine
• At least 10 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines
• Competent with Project Management tools and software
• Excellent communication skills, strategic thinker, solution orientated
• Ability to work independently and manage multiple tasks simultaneously under time constraints. Flexible with excellent prioritisation skills